Trial · NCT03311854
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence, Severity, Causality, and Outcomes of AEs (Serious and Nonserious) | Up to Week 8 | |
| Primary | Evolution of Laboratory Parameters | Up to Week 8 | Shifts from baseline in the following MAS-relevant laboratory parameters are reported: * Leukocytes * Platelets * Lactate dehydrogenase (LDH) * Alanine aminotransferase (ALT) * Aspartate aminotransferase (AST) * Ferritin * C-reactive protein * Activated partial thromboplastin time (aPTT) * Prothrombin time * D-dimer * Fibrinogen |
| Primary | Number of Participants Withdrawn Due to Safety Reasons | Up to Week 8 | |
| Primary | Number of Participants Achieving MAS Remission at Week 8 After Initiation of Emapalumab Treatment | Week 8 | Remission from MAS was evaluated according to the following criteria: Resolution of clinical signs and symptoms according to the investigator (MAS clinical signs and symptoms activity score ≤ 1) and Normalization of laboratory parameters relevant to MAS, as follows: * WBC count and platelet count above the LLN. * LDH below 1.5 × the ULN. * ALT and AST both below 1.5 × the ULN. * Fibrinogen higher than 100 mg/dL. * Ferritin levels decreased by at least 80 % from values at screening or baseline (whichever was higher) or below 2000 ng/mL, whichever was lower. |
| Primary | Time to First MAS Remission | Up to Week 8 | |
| Primary | Number of Participants for Whom Glucocorticoids Could be Permanently Tapered at Any Time During the Study | Up to Week 8 | Permanently tapering by at least 50% of the equivalent dose of prednisone. This was defined as achieving reduction of 50% of the baseline dose \[SD0\] and maintaining the reduction until the end of study). |
| Primary | Time to Achievement of Permanent Glucocorticoids Tapering | Up to Week 8 | Time to achievement of permanent glucocorticoid tapering by at least 50% of the equivalent dose of prednisone administered at emapalumab treatment start. |
| Primary | Survival Time | Up to Week 8 | Number of participants alive at the end of the study |
| Primary | Number of Participants Withdrawn From the Study Due to Lack of Efficacy | Up to Week 8 | Number of participants withdrawn from the study due to lack of efficacy |
| Primary | Levels of Emapalumab Concentration | Data from the following time points are presented: SD0 (pre- and post-dose), Week 4 Visit 2 (pre- and post-dose), and 4-week follow-up visit/EoS. | On all infusion days, PK samples were collected before the infusion start and between 15 and 30 minutes after infusion completion. In addition, following the first emapalumab infusion, PK samples were collected approximately 24 and 48 hours post-infusion, and following the second emapalumab infusion, PK samples were collected approximately 48 hours post-infusion. Upon treatment completion, PK samples were collected on all non-infusion visits until the 4-week follow-up visit/EOS. |
| Primary | Pharmacodynamic Parameters | Up to Week 8 | Levels of total INF-gamma, CXCL9 and CXCL10 |
| Primary | Number of Participants Who Demonstrated a Presence of Circulating Antibodies Against Emapalumab to Determine Immunogenicity | Up to Week 8 | The presence of circulating antibodies against emapalumab was inferred by positive results for anti-drug antibodies (ADAs). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT03311854/registered